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Background: This paper aims to promote the use of interrupted time series analyses of routine data as a responsive feedback tool to improve public health programs on an ongoing basis. This methodology is demonstrated by measuring the effect of a radio campaign to promote a family planning call center in Nigeria on the demand for family planning information and explains how the results were used to adapt the program. Methods: We used a single group interrupted time series design (ITS) as a responsive feedback mechanism to determine whether the radio campaign influenced use of the Honey&Banana call center. ITS is ideal when a control group is not available and assumes that an interruption of the trend in the outcome measure occurs after the intervention starts. ITS uses the pre-intervention trend to predict what would have happened if the intervention were absent. Results: After conducting ITS analyses, the results show that the number of calls requesting family planning information increased throughout the campaign period, with a gain of about 500 additional calls per month, and then decreased after the campaign ended. However, the number of calls gained from the campaign was substantially lower than anticipated. Conclusions: While end-of-project impact evaluations are necessary, there should be regular feedback system to provide program implementers with information about the status of the project, such as failures, successes, and areas of improvements. This would allow implementers to make necessary adjustments as needed throughout the intervention period. The finding that the radio campaign was not living up to expectations helped program implementers to end the campaign prematurely and re-allocate resources to a more promising activity. Our research shows that basic ITS analysis of routine data can be a useful tool for receiving regular feedback to guide programming improvements.

Background: The California mastitis test (CMT) is a simple cow-side indicator of the somatic cell count (SCC) in milk, providing a useful tool in identifying cases of subclinical mastitis in cattle. Mastitis, and in particular subclinical mastitis, is a major concern in Ethiopia and Nigeria, yet detection is challenging due to cost and access to commercial CMT reagents. Methods: Commercially available domestic detergents from Ethiopia and Nigeria were compared (n = 3 for each country) with the UK commercial CMT reagent in their ability to detect high SCC (>400,000 cells/ml milk). Sensitivity and specificity of the CMT test were calculated for the different detergents and positive and negative predictive values were established. Results: The average sensitivities of the tests ranged from 28-75% for the Ethiopian detergents and 68-80% for the Nigerian detergents, compared to 76% for the UK domestic detergent. Test specificities were 84-98%, 93-97% and 96%, respectively. Conclusions: Overall, the detergents demonstrated higher specificity than sensitivity. Nigerian detergents performed better than the Ethiopian products, however, the study identified suitable domestic detergents from both Ethiopia and Nigeria, comparable to the UK commercial CMT reagent, and we recommend their use as alternative CMT reagents for livestock-keepers to aid in cost-effective diagnosis of mastitis.

Maternal and newborn infections are a major contributor to mortality and morbidity globally. Lost-cost, effective and safe interventions are needed to address these. Based on promising findings, azithromycin has been identified as potentially effective antibiotic to reduce maternal and newborn infections in low- and middle-income countries (LMICs). However, robust randomized clinical trials in a range of settings are needed to confirm these findings as well as to understand the implications for antimicrobial resistance. To better understand the impact of azithromycin on maternal and newborn health, at least three clinical trials are being conducted to evaluate azithromycin in LMICs. We describe these trials, the importance of harmonizing study measures and the potential public health impact of azithromycin in LMICs.

Background: Under-5 pneumonia mortality remains high in low-income countries. In 2014 the World Health Organization (WHO) advised that children with chest indrawing pneumonia, but without danger signs or peripheral oxygen saturation (SpO2) < 90% be treated in the community, rather than hospitalized. In Malawi there is limited pulse oximetry availability. Methods: Secondary analysis of 13,413 under-5 pneumonia cases in Malawi. Pneumonia associated case fatality ratios (CFR) were calculated by disease severity under the assumptions of the 2005 and 2014 WHO Integrated Management of Childhood Illness (IMCI) guidelines, with and without pulse oximetry. We investigated if pulse oximetry readings were missing not at random (MNAR). Results: The CFR of patients classified as having non-severe pneumonia per the 2014 IMCI guidelines doubled under the assumption that pulse oximetry was not available (1.5% without pulse oximetry vs 0.7% with pulse oximetry, P2 < 90% as the threshold for referral and/or admission, the number of cases meeting hospitalization criteria decreased by 70.3%. Unrecorded pulse oximetry readings were MNAR with an adjusted odds for mortality of 4.9 (3.8, 6.3), similar to that of a SpO2 < 90%. Although fewer girls were hospitalized, female sex was an independent mortality risk factor. Conclusions: In Malawi, implementation of the 2014 WHO IMCI pneumonia guidelines, without pulse oximetry, will miss high risk cases. Alternatively, implementation of pulse oximetry may result in a large reduction in hospitalization rates without significantly increasing non-severe pneumonia associated CFR if the inability to obtain a pulse oximetry reading is considered a WHO danger sign.

Purpose: This study qualitatively examines the efforts of implementing teacher-led collaborative inquiry in American public schools to improve instruction. We focus on a model called Teacher Peer Excellence Group (TPEG), designed to capture the essence of Japanese lesson study and Chinese teaching-study groups that involve lesson planning, peer observations, feedback, and revision. Methods: We conduct qualitative case studies in three pilot schools using a constructivist research paradigm. Findings: We identify action steps essential to introducing and sustaining the TPEG model and pathways to local adaptation. Implications for research and practice: The study contributes to the body of research that seeks to understand the role of instructional leadership and teacher decision-making in successful school-level initiatives.

Background The global prevalence of diseases transmitted by Aedes aegypti mosquitoes, such as dengue, Zika and Yellow Fever, is increasing, but development of promising new mosquito control technologies could reverse this trend. Target Product Profiles (TPPs) and Preferred Product Characteristics (PPCs) documents issued by the World Health Organization can guide the research and development pathways of new products and product combinations transitioning from proof of concept to operational use. Methods We used high resolution global maps of the case and economic burden of dengue to derive programmatic cost targets to support a TPP for Wolbachia replacement. A compartmental entomological model was used to explore how release size, spacing and timing affect replacement speed and acceptability. To support a PPC for a hybrid suppress-then-replace approach we tested whether Wolbachia replacement could be achieved faster, more acceptably or at a lower cost if preceded by a mosquito suppression programme. Results We show how models can reveal trade-offs, identify quantitative thresholds and prioritise areas and intervention strategies for further development. We estimate that for Wolbachia replacement to be deployable in enough areas to make major contributions to reducing global dengue burden by 25% (in line with 2030 WHO targets), cost must ultimately be reduced to between $7.63 and $0.24 (USD) per person protected or less. Suppression, particularly interventions that induce mosquito sterility, can reduce the number of Wolbachia mosquitoes necessary to achieve fixation by up to 80%. A hybrid approach can also achieve fixation faster and potentially improve acceptability, but may not justify their cost if they require major new investments in suppression technologies. Conclusions Here we demonstrate the value dedicated modelling can provide for interdisciplinary groups of experts when developing TPPs and PPCs. These models could be used by product developers to prioritise and shape development decisions for new Wolbachia replacement products.

Background: This study examines the association between family planning (FP) discussions with health professionals during contact points on the maternal, newborn and child health continuum of care and timing of modern contraceptive uptake and method type in the one-year following childbirth in six regions of Ethiopia among adolescent girls and young women (AGYW). Methods: This paper uses panel data of women aged 15-24 who were interviewed during pregnancy and the postpartum period between 2019-2021 as part of the PMA Ethiopia survey (n=652). Results: Despite the majority of pregnant and postpartum AGYW attending antenatal care (ANC), giving birth in a health facility, and attending vaccination visits, one-third or less of those who received the service reported discussion of FP at any of these visits. When considering the cumulative effect of discussions of FP at ANC, pre-discharge after childbirth, postnatal care and vaccination visits, we found that discussion of FP at a greater number of visits resulted in increased uptake of modern contraception by one-year postpartum. A greater number of FP discussions was associated with higher long-acting reversible contraceptive use relative to non-use and relative to short-acting method use. Conclusions: Despite high attendance, there are missed opportunities to discuss FP when AGYW access care.

Background: Injections are Pakistan's third most preferred contraceptive method because of their convenience. They represent a 2.5% share of the contraceptive prevalence rate (CPR) and contribute 10% to the current CPR. However, injections require a clinical setting or a healthcare provider for administration. A new method of subcutaneous presentation of depot medroxyprogesterone acetate (DMPA-SC), namely Sayana Press in Uniject™, has been introduced, which can be administered in nonclinical settings or self-administered by trained women. This study examined clients’ perceptions of the current depot medroxyprogesterone acetate-intramuscular injection (DMPA-IM) and its accessibility, availability, affordability, advantages, and disadvantages. In addition, it explored the benefits, barriers, and challenges regarding the new method of DMPA-SC (Sayana Press), especially considering self-injection. Methods: The study was conducted in Sindh, Pakistan. Three focus group discussions were conducted with 9–13 female participants with different demographic characteristics. A semi-structured questionnaire was used. The discussion was recorded, transcribed, and translated from Urdu or Sindhi to English. Transcripts were coded precisely, and data analysis was performed using NVivo software. Results: Participants expressed moderate fear of self-injection and risk of an inaccurate prick, suggesting that DMPA-SC acceptance may not be challenging at a community level. They appreciated free services at public health facilities, as the affordability of private facilities may be challenging for those with low income. Most participants agreed to pay PKR 50–300 (approximately 1 USD or less) as service charges for a private facility, while some agreed to pay for transportation costs when lacking alternative methods. Conclusions: DMPA-SC is a valuable alternative, provided its challenges are adequately addressed. Information about self-injection contraceptives is currently limited, and shared self-administration may be difficult without adequate training and counseling. Nevertheless, clients prefer the self-injection method for family planning to avoid transportation and private service charges.

Background: Since 2017 global guidelines have recommended “same-day initiation” (SDI) of antiretroviral treatment (ART) for patients considered ready for treatment on the day of HIV diagnosis. Many countries have incorporated a SDI option into national guidelines, but SDI uptake is not well documented. We estimated average time to ART initiation at 12 public healthcare facilities in Malawi, five in South Africa, and 12 in Zambia. Methods: We identified patients eligible to start ART between January 2018 and June 2019 from facility testing registers and reviewed their medical records from HIV diagnosis to the earlier date of treatment initiation or 6 months. We estimated the proportion of patients initiating ART on the same day or within 7, 14, 30, or 180 days of baseline. Results: We enrolled 825 patients in Malawi, 534 in South Africa, and 1,984 in Zambia. Overall, 88% of patients in Malawi, 57% in South Africa, and 91% in Zambia received SDI. In Malawi, most who did not receive SDI had not initiated ART ≤6 months. In South Africa, an additional 13% initiated ≤1 week, but 21% had no record of initiation ≤6 months. Among those who did initiate within 6 months in Zambia, most started ≤1 week. There were no major differences by sex. WHO Stage III/IV and tuberculosis symptoms were associated with delays in ART initiation; clinic size and having a CD4 count done were associated with an increased likelihood of SDI. Conclusions: As of 2020, SDI of ART was widespread, if not nearly universal, in Malawi and Zambia but considerably less common in South Africa. Limitations of the study include pre-COVID-19 data that do not reflect pandemic adaptations and potentially missing data for Zambia. South Africa may be able to increase overall ART coverage by reducing numbers of patients who do not initiate ≤6 months.

Background: The COVID-19 pandemic affected global access to health services, including contraception We sought to explore effects of the pandemic on family planning (FP) service provision and use in South Africa and Zambia, including on implant and intrauterine device (IUD) users’ desire and ability to obtain removal. Methods: Between August 2020 and April 2021, we conducted surveys with 537 women participating in an ongoing longitudinal contraceptive continuation study. We also carried out in-depth interviews with 39 of the survey participants and 36 key informants involved in FP provision. We conducted descriptive analysis of survey responses and thematic analysis of interviews. Results: Contraceptive use changed minimally in this sample with the emergence of COVID-19. Fewer than half of women (n=220) reported attempting to access FP since the start of the pandemic, the vast majority using short-acting methods. Among those who sought services, 95% obtained their preferred method. The proportion of women not using a method before and after pandemic start did not change in Zambia (31%); in South Africa, the proportion increased from 8% to 10%. Less than 7% of implant or IUD users in either country reported wanting removal. Among those who sought removal (n=22), 91% (n=10) in Zambia and 55% (n=6) in South Africa successfully obtained removal. In qualitative interviews, women with challenges accessing FP services mentioned long queues, deprioritization of contraceptive services, lack of transportation, stock-outs, and fear of contracting COVID-19 at a facility. Key informants reported stock-outs, especially of injectables, and staff shortages as barriers. Conclusions: We did not find a substantial impact of COVID-19 on contraceptive access among this sample; however, providers and others involved in service provision identified risks to continuity of care. As the COVID-19 pandemic wanes, it continues to be important to monitor people’s ability to access their preferred contraceptive methods.

Background: Extreme hyperbilirubinemia leading to neurologic disability and death is disproportionately high in low to middle income countries (LMIC) such as Bangladesh, and is largely preventable through timely treatment. Of the estimated 50% of newborns born in LMICs born at home, few receive screening or treatment for hyperbilirubinemia, leading to 6 million newborns per year who need phototherapy treatment for hyperbilirubinemia but are untreated. Household screening and treatment for neonatal hyperbilirubinemia with phototherapy administered by a trained community health worker (CHW) may increase indicated treatment for neonatal hyperbilirubinemia in comparison to the existing care system in Bangladesh. Methods: 530 Bangladeshi women in their 2nd or 3rd trimester of pregnancy from the rural community of Sakhipur, Bangladesh will be recruited for a cluster randomized trial and randomized to the intervention arm — home screening and treatment for neonatal hyperbilirubinemia — or the comparison arm to receive usual care. In the intervention arm, CHWs will provide mothers with two prenatal visits, visit newborns by 2 days of age and then daily for 3 days to measure transcutaneous bilirubin (TcB) and monitor clinical danger signs. Newborns without danger signs but with a TcB above the treatment threshold >15 mg/dL will be referred to a hospital for treatment. Treatment rates for neonatal hyperbilirubinemia in each arm will be compared. Conclusion: This study will evaluate the effectiveness of CHW-led home phototherapy to increase neonatal hyperbilirubinemia treatment rates in rural Bangladesh. LMICs are expanding access to postnatal care by using CHWs, and our work will give CHWs a curative treatment option for neonatal hyperbilirubinemia. Similar projects in other LMICs can be pursued to dramatically extend healthcare access to vulnerable newborns with hyperbilirubinemia.

Background: A large proportion of clinical trials end without delivering results that are useful for clinical, policy, or research decisions. This problem is called “uninformativeness”. Some high-risk indicators of uninformativeness can be identified at the stage of drafting the protocol, however the necessary information can be hard to find in unstructured text documents. Methods: We have developed a browser-based tool which uses natural language processing to identify and quantify the risk of uninformativeness. The tool reads and parses the text of trial protocols and identifies key features of the trial design, which are fed into a risk model. The application runs in a browser and features a graphical user interface that allows a user to drag and drop the PDF of the trial protocol and visualize the risk indicators and their locations in the text. The user can correct inaccuracies in the tool’s parsing of the text. The tool outputs a PDF report listing the key features extracted. The tool is focused HIV and tuberculosis trials but could be extended to more pathologies in future. Results: On a manually tagged dataset of 300 protocols, the tool was able to identify the condition of a trial with 100% area under curve (AUC), presence or absence of statistical analysis plan with 87% AUC, presence or absence of effect estimate with 95% AUC, number of subjects with 69% accuracy, and simulation with 98% AUC. On a dataset of 11,925 protocols downloaded from ClinicalTrials.gov, the tool was able to identify trial phase with 75% accuracy, number of arms with 58% accuracy, and the countries of investigation with 87% AUC. Conclusion: We have developed and validated a natural language processing tool for identifying and quantifying risks of uninformativeness in clinical trial protocols. The software is open-source and can be accessed at the following link: https://app.clinicaltrialrisk.org

Background: The polio eradication endgame continues to increase in complexity. With polio cases caused by wild poliovirus type 1 and circulating vaccine-derived polioviruses of all three types (1, 2 and 3) reported in 2022, the number, formulation, and use of poliovirus vaccines poses challenges for national immunization programs and vaccine suppliers. Prior poliovirus transmission modeling of globally-coordinated type-specific cessation of oral poliovirus vaccine (OPV) assumed creation of Sabin monovalent OPV (mOPV) stockpiles for emergencies and explored the potential need to restart OPV if the world reached a specified cumulative threshold number of cases after OPV cessation. Methods: We document the actual experience of type 2 OPV (OPV2) cessation and reconsider prior modeling assumptions related to OPV restart. We develop updated decision trees of national immunization options for poliovirus vaccines considering different possibilities for OPV restart. Results: While OPV restart represented a hypothetical situation for risk management and contingency planning to support the 2013-2018 Global Polio Eradication Initiative (GPEI) Strategic Plan, the actual epidemiological experience since OPV2 cessation raises questions about what, if any, trigger(s) could lead to restarting the use of OPV2 in routine immunization and/or plans for potential future restart of type 1 and 3 OPV after their respective cessation. The emergency use listing of a genetically stabilized novel type 2 OPV (nOPV2) and continued evaluation of nOPV for types 1 and/or 3 add further complexity by increasing the combinations of possible OPV formulations for OPV restart. Conclusions: Expanding on a 2019 discussion of the logistical challenges and implications of restarting OPV, we find a complex structure of the many options and many issues related to OPV restart decisions and policies as of early 2023. We anticipate many challenges for forecasting prospective vaccine supply needs during the polio endgame due to increasing potential combinations of poliovirus vaccine choices.

Background: Circulating vaccine derived poliovirus (cVDPV) outbreaks remain a threat to polio eradication. To reduce cases of polio from cVDPV of serotype 2, the serotype 2 component of the vaccine has been removed from the global vaccine supply, but outbreaks of cVDPV2 have continued. The objective of this work is to understand the factors associated with later detection in order to improve detection of these unwanted events. Methods: The number of nucleotide differences between each cVDPV outbreak and the oral polio vaccine (OPV) strain was used to approximate the time from emergence to detection. Only independent emergences were included in the analysis. Variables such as serotype, surveillance quality, and World Health Organization (WHO) region were tested in a negative binomial regression model to ascertain whether these variables were associated with higher nucleotide differences upon detection. Results: In total, 74 outbreaks were analysed from 24 countries between 2004-2019. For serotype 1 (n=10), the median time from seeding until outbreak detection was 284 (95% uncertainty interval (UI) 284-2008) days, for serotype 2 (n=59), 276 (95% UI 172-765) days, and for serotype 3 (n=5), 472 (95% UI 392-603) days. Significant improvement in the time to detection was found with increasing surveillance of non-polio acute flaccid paralysis (AFP) and adequate stool collection. Conclusions: cVDPVs remain a risk; all WHO regions have reported at least one VDPV outbreak since the first outbreak in 2000 and outbreak response campaigns using monovalent OPV type 2 risk seeding future outbreaks. Maintaining surveillance for poliomyelitis after local elimination is essential to quickly respond to both emergence of VDPVs and potential importations as low-quality AFP surveillance causes outbreaks to continue undetected. Considerable variation in the time between emergence and detection of VDPVs were apparent, and other than surveillance quality and inclusion of environmental surveillance, the reasons for this remain unclear.

Background: South African adolescents experience disproportionally high rates of violence, with lifelong health, social and economic impacts. Few papers present risk factors associated with experiences of adolescent violence. Methods: A baseline cross-sectional survey was done (April 2017 – Sept 2018) with 3432 grade 8 learners in the Girls Achieve Power (GAP Year) trial from 26 high schools in three townships (Soweto and Tembisa, Gauteng and Khayelitsha, Western Cape). Collected data on lifetime experiences of different types of violence, perpetrators, and place of violence. Descriptive statistics and logistic regression were used to enumerate experiences of, and factors associated with violence. Results: A total of 2383 respondents are included. Most (63.1%) were girls, 81.5% aged 12-14. In total 25.9% had ever experienced violence, higher among boys (p= Multivariate analysis showed that boys (aOR 1.68; 95% CV 1.32-2.14; p Conclusion: Urgently need wider adoption, scaling, and sustaining of evidence-based primary violence prevention and structural interventions are required to reduce the high burden of adolescent violence. Stakeholders across the ecological model are needed to tackle harmful cultural norms that perpetuate violence.

Background: Social norms have long been understood as essential for demographic preferences, intentions and behavior, despite a lack of consistent definitions and measures in the field. Recent work has more clearly defined these norms, both at the individual and community/collective levels. However, past research on the effect of social norms on contraceptive use has focused mainly on the influence of individual-level norms, largely among women only, contributing to mixed findings. Methods: This study addresses this gap through the use of multilevel models to identify associations between collective gender, fertility, and family planning norms and individual use of modern contraceptives for both men and women, using recent Demographic and Health Survey (DHS) data from Nigeria and Zambia. Multiple measures of variation, including community-level random effects and the intraclass correlation, are calculated, providing evidence of the general effect of community factors on behavior. Results: Our findings support the importance of social, demographic and economic context on how collective gender, fertility, and family planning norms relate to modern contraceptive use. Different social norms are associated with use in the two countries, and, even within the same country, men and women’s use are influenced by different norms. Among the examined norms, only collective fertility norms were associated with use for all the groups examined, consistently associated with lower use of modern contraception. Overall, clustering at the community level explained a larger proportion of variance in individual use in men compared to women, suggesting that men’s behavior was more consistently associated with the measured social norms than women’s. Conclusions: These findings suggest that careful attention should be paid to understanding and measuring social norms when considering programs or policy around the provision of modern contraception and that these should not assume that social norms influence men and women’s behaviors in the same way.

Background: In many countries, non-pharmaceutical interventions to limit severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) transmission resulted in significant reductions in other respiratory viruses. However, similar data from Africa are limited. We explored the extent to which viruses such as influenza and rhinovirus co-circulated with SARS-CoV-2 in The Gambia during the COVID-19 pandemic. Methods: Between April 2020 and March 2022, respiratory viruses were detected using RT-PCR in nasopharyngeal swabs from 1397 participants with influenza-like illness. An assay to detect SARS-CoV-2 and a viral multiplex RT-PCR assay was used as previously described to detect influenza A and B, respiratory syncytial virus (RSV) A and B, parainfluenza viruses 1-4, human metapneumovirus (HMPV), adenovirus, seasonal coronaviruses (229E, OC43, NL63) and human rhinovirus. Results: Overall virus positivity was 44.2%, with prevalence higher in children 50 years (39.9%), p50 years (24.3%), p50 years (6.3%), p Conclusion: Our data show that many respiratory viruses continued to circulate during the COVID-19 pandemic in The Gambia, including human rhinoviruses, despite the presence of NPIs during the early stages of the pandemic, and influenza peaks during expected months.

Background: The HIV Prevention Self-Assessment Tools (PSATs) were developed by the Global Prevention Coalition as an easy-to-use tool for country-led review of national HIV prevention response against a global standardised set of programmatic components. As part of the South to South Learning Network (SSLN), country-level data on HIV prevention programmes for sex workers were collected by 10 African countries, using the PSAT to self-assess their HIV prevention progress. Methods: Data were collected August 2020 to July 2021 from participating countries. In each country, a technical team of 8-10 members completed the tool with support from the SSLN. The PSAT collects data for three programme domains: management, implementation and outcomes and sustainability, each of which comprises essential programme functions and elements. Once all elements are scored, the tool automatically calculates the final scores for each domain, on a scale of 1-5. Also, 15 interviews were conducted with 15 country leaders to understand the ease and usefulness of the PSAT process. Results: The overall PSAT scores ranged between 4.1 (Kenya) to 2.3 in Zambia. Of the three domains, Programme Management achieved the highest scores, with four countries (Kenya, Ghana, Zimbabwe, and South Africa) scoring more than four. High scores were seen in the Programme Implementation domain as well; five countries (Zimbabwe, South Africa, Mozambique, Malawi and Uganda) scored between 3 to 4. For Programme Outcomes and Sustainability, other than Kenya, which did not score the outcomes, all countries scored poorly with scores ranging between 3.8 to 1.5. Comparing PSAT scores with UNAIDS suggested epidemic metrics have shown that countries with the highest PSAT scores also have high condom use rates and significant reductions in HIV incidence from 2010 to 2019. Conclusions: This exercise has helped country’s leadership to self-reflect on their HIV prevention programmes, increase ownership and identify areas that need strengthening.

Background: Tenofovir regimens remain the preferred formulations in the HIV guidelines for adolescents and young adults in Zambia and globally. However, some adolescents and young adults are maintained on abacavir by clinicians because of anxiety about possible proximal tubular dysfunction from tenofovir. We assessed the effect of two regimens on proximal tubular function in adolescents and young adults living with HIV. Methods: This was a cross-sectional study involving 180 participants with HIV receiving either tenofovir or abacavir for ≥12 months at the largest tertiary teaching hospital. Two first-morning urine and blood specimens were collected and analyzed for proximal tubular markers, glomerular function, electrolytes, and routine monitoring tests. Proximal tubular function was determined by measuring the fractional excretion of phosphate (FePO4). Proximal tubular dysfunction was defined by FePO4 ≥20% regardless of serum phosphate and FePO4 ≥10-20% when serum phosphate was below 0.81mmol/L. Results: The prevalence of proximal tubular dysfunction was 6% and was higher in the tenofovir group than the abacavir (10% vs. 2%, p2-microglobulin: creatinine ratio, C-reactive protein, and urine protein: creatinine ratio was all associated with worsening proximal tubular dysfunction. Reduced estimated glomelurar filtration rate (eGFR) was found in four (2.2%) participants; three of which were on tenofovir. Conclusions: Proximal tubular dysfunction defined by FePO4 was more prevalent in the tenofovir group than the abacavir group, but not after adjusting for age. Our findings should be interpreted with caution as age differences between the two groups confounded the results.

Background: The Masimo Total Hemoglobin SpHb® is a continuous and non-invasive handheld device to measure hemoglobin levels. Previous research has found that SpHb is able to accurately detect hemoglobin levels in adult patients with a similar degree of bias and standard deviation to point-of-care invasive method measurements. Generally, limited clinical evidence, lack of validation of Masimo at higher than and lower than hemoglobin threshold values, and scientific consensus supporting the use of Masimo for accurate hemoglobin testing for the diagnosis of anemia during pregnancy calls for further research. Methods and analysis: The proposed prospective cohort will be nested within the ongoing Pregnancy Risk and Infant Surveillance and Measurement Alliance (PRISMA) Maternal and Newborn Health (MNH) study. Three study sites (located in Zambia, Kenya, and Pakistan) will participate and collect hemoglobin data at five time points ( Conclusions: The primary aim of this study is to assess the validity of the non-invasive Masimo device compared to the gold standard method of invasive hemoglobin measurements during pregnancy and postpartum periods for the diagnosis of anemia.

It is uncertain whether malaria is an important cause of death among adults in endemic areas. We performed a chart review of adults admitted to Bo Government Hospital during 2019. Of 893 admissions, 149 (59% female, mean age 58.5 years) had a laboratory diagnosis of malaria and 22 (14.8%) died. Mortality was significantly higher among patients with severe malaria compared with those who had non-severe malaria (6/20 [30%] versus 16/129 [12.4%], p=0.031). Our results suggest that malaria is a common cause of death in hospitalized Sierra Leonian adults.

Background: The dumping of untreated faecal sludge from non-sewered onsite sanitation facilities causes environmental pollution and exacerbates poor public health outcomes across developing nations. Long-term mechanisms to treat faecal sludge generated from these facilities are needed to resolve the global sanitation crisis and realize the Sustainable Development Goal (SDG) 6 “ensure availability and sustainable management of water and sanitation for all” by 2030. Pyrolysis of faecal sludge removes pathogens and generates biochar, which can be used as a soil enhancer. Methods: The properties of faecal sludge biochars from three full-scale treatment plants in India were determined via Fourier transform infrared (FTIR) spectroscopy, scanning electron microscopy (SEM), energy dispersive x-ray (EDX) spectroscopy, crystal x-ray diffraction (XRD), proximate analyses, and BET surface area porosimetry. Results: Results showed that all three biochars had low specific surface area, high alkaline pH values, high ash content, and negative surface charge. Fourier transform infrared spectra showed the same surface functional groups present in each biochar. X-ray diffraction analysis showed the mineral composition of each biochar differed slightly. Scanning electron microscopy analysis indicated a porous structure of each biochar with ash particles evident. Conclusions: Slight differences in the ash content, surface area, pH and mineral content was observed between the three biochars.

Background: In many countries, non-pharmaceutical interventions to limit severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) transmission resulted in significant reductions in other respiratory viruses. However, similar data from Africa are limited. We explored the extent to which viruses such as influenza and rhinovirus co-circulated with SARS-CoV-2 in The Gambia during the COVID-19 pandemic. Methods: Between April 2020 and March 2022, respiratory viruses were detected using RT-PCR in nasopharyngeal swabs from 1397 participants with influenza-like illness. An assay to detect SARS-CoV-2 and a viral multiplex RT-PCR assay was used as previously described to detect influenza A and B, respiratory syncytial virus (RSV) A and B, parainfluenza viruses 1-4, human metapneumovirus (HMPV), adenovirus, seasonal coronaviruses (229E, OC43, NL63) and human rhinovirus. Results: Overall virus positivity was 44.2%, with prevalence higher in children 50 years (39.9%), p50 years (24.3%), p50 years (6.3%), p Conclusion: Our data show that many respiratory viruses continued to circulate during the COVID-19 pandemic in The Gambia, including human rhinoviruses, despite the presence of NPIs during the early stages of the pandemic, and influenza peaks during expected months.

Background: The contribution of sudden unexpected infant death (SUID) has received little attention in global health. The objective of this study was to estimate the burden of SUID in Lusaka, Zambia. Methods: Verbal autopsies were conducted on infants who died in Lusaka, between 2017 and 2020. From these, we performed a qualitative analysis of the free text narratives of the final series of events leading to each infant’s death and classified these as symptomatic deaths or SUID. Any narrative that described an infant who was otherwise healthy with no antecedent illness prior to death and found dead in bed after a sleep episode was classified as SUID. We used logistic regression to test for statistical differences between asymptomatic deaths and SUIDs on key infant, maternal and other risk factors of SUIDs. Results: Eight hundred and nine verbal autopsies were conducted with families of decedent infants younger than six months of age. A total of 92.6% (749/809) had presented with symptoms prior to death, whereas 7.4% (60/809) died without preceding symptoms or obvious cause of death. Of these, 16/60 were compatible with accidental suffocation deaths, and 54/60 appeared to be sudden infant death syndrome. SUID deaths were concentrated in infants younger than two months of age with peak age of one to two months. Age at death was the only significant factor in multivariate analysis. Infants aged between one and two months had 2.84 increased odds of suspected SUIDs compared to infants in the first month of life (aOR = 2.84, 95% CI: 1.31, 6.16). Conclusions: Our findings suggest SUID could be accounting for a significant proportion of infant deaths in Zambia, but this cause of infant mortality is going unrecognized. Public health interventions in Zambia, and Africa more broadly, are likely overlooking SUIDs as an important cause of infant mortality.

Background Malaria in pregnancy is a major public health problem in sub-Saharan Africa (SSA), which imposes a significant economic burden. We provide evidence on the costs of malaria care in pregnancy to households and the health system in four high-burden countries in SSA. Methods Household and health system economic costs associated with malaria control in pregnancy were estimated in selected areas of the Democratic Republic of Congo (DRC), Madagascar (MDG), Mozambique (MOZ) and Nigeria (NGA). An exit survey was administered to 2,031 pregnant women when leaving the antenatal care (ANC) clinic from October 2020 to June 2021. Women reported the direct and indirect costs associated to malaria prevention and treatment in pregnancy. To estimate health system costs, we interviewed health workers from 133 randomly selected health facilities. Costs were estimated using an ingredients-based approach. Results Average household costs of malaria prevention per pregnancy were USD6.33 in DRC, USD10.06 in MDG, USD15.03 in MOZ and USD13.33 in NGA. Household costs of treating an episode of uncomplicated/complicated malaria were USD22.78/USD46 in DRC, USD16.65/USD35.65 in MDG, USD30.54/USD61.25 in MOZ and USD18.92/USD44.71 in NGA, respectively. Average health system costs of malaria prevention per pregnancy were USD10.74 in DRC, USD16.95 in MDG, USD11.17 in MOZ and USD15.64 in NGA. Health system costs associated with treating an episode of uncomplicated/complicated malaria were USD4.69/USD101.41 in DRC, USD3.61/USD63.33 in MDG, USD4.68/USD83.70 in MOZ and USD4.09/USD92.64 in NGA. These estimates resulted in societal costs of malaria prevention and treatment per pregnancy of USD31.72 in DRC, USD29.77 in MDG, USD31.98 in MOZ and USD46.16 in NGA. Conclusions Malaria in pregnancy imposes a high economic burden on households and the health system. Findings emphasize the importance of investing in effective strategies that improve access to malaria control and reduce the burden of the infection in pregnancy.

Background: Since 2017 global guidelines have recommended “same-day initiation” (SDI) of antiretroviral treatment (ART) for patients considered ready for treatment on the day of HIV diagnosis. Many countries have incorporated a SDI option into national guidelines, but SDI uptake is not well documented. We estimated average time to ART initiation at 12 public healthcare facilities in Malawi, five in South Africa, and 12 in Zambia. Methods: We sequentially enrolled patients eligible to start ART between January 2018 and June 2019 and reviewed their medical records from the point of HIV diagnosis or first HIV-related interaction with the clinic to the earlier date of treatment initiation or 6 months. We estimated the proportion of patients initiating ART on the same day or within 7, 14, 30, or 180 days of baseline. Results: We enrolled 826 patients in Malawi, 534 in South Africa, and 1,984 in Zambia. Overall, 88% of patients in Malawi, 57% in South Africa, and 91% in Zambia were offered and accepted SDI. In Malawi, most who did not receive SDI had not initiated ART ≤6 months. In South Africa, an additional 13% initiated ≤1 week, but 21% had no record of initiation ≤6 months. Among those who did initiate within 6 months in Zambia, most started ≤1 week. There were no major differences by sex. WHO Stage III/IV and tuberculosis symptoms were associated with delays in ART initiation. Conclusions: As of 2020, SDI of ART was widespread, if not nearly universal, in Malawi and Zambia but considerably less common in South Africa. Limitations of the study include pre-COVID-19 data that do not reflect pandemic adaptations and potentially missing data for Zambia. South Africa may be able to increase overall ART coverage by reducing numbers of patients who do not initiate ≤6 months. Registration: Clinicaltrials.gov (NCT04468399; NCT04170374; NCT04470011).

Background: To better comprehend the demand for online medication abortion and to inform service delivery practice, we conducted an analysis of Women Help Women (WHW) service delivery statistics. The primary goals were to understand their user profile, evaluate self-reported outcomes and use of other medical services, and assess the overall experience both with the abortion itself and with the counseling and care provided by WHW. Methods: We retrospectively evaluated user characteristics, abortion outcomes, and acceptability of both the medication abortion and WHW’s services, using consultation data and corresponding evaluation data from a one-year period. For users who did not complete the evaluation form, WHW staff reviewed email correspondences to identify key outcomes. Results: From August 2016-July 2017, 3,307 individuals received abortion pills from WHW. Users were geographically located in thirty countries and correspondence was conducted in seven languages. Most reported their gestational age to be less than eight weeks. Of the 2,295 who took the pills and provided outcome information, almost all (99.1%, n=2275) reported that they were no longer pregnant. The majority (84.1%, n=1576/1875) used symptoms to confirm outcome; one fourth (22.8%, n=428) sought an ultrasound and one sixth (18.0%, n=338) used urine and/or serum testing. One in eight users (12.6%, n=292/2317) reported seeking additional medical care after taking the abortion pills. Most (87.5%, n=1551/1773) reported being satisfied or very satisfied with the abortion. Conclusions: Our study confirms that self-managed abortion is a process that people can do safely and effectively with community support and without medical supervision. In the context of a global backlash against abortion rights, self-managed abortion is an integral part of a spectrum of options for abortion care that must be made available to all.

Background HIV-associated tuberculosis (TB) has high mortality; however, current triage and prognostic tools offer poor sensitivity and specificity, respectively. We conducted a systematic review of diagnostic and prognostic host-blood transcriptomic signatures of TB in people living with HIV (PLHIV). Methods We systematically searched online databases for studies published in English between 1990-2020. Eligible studies included PLHIV of any age in test or validation cohorts, and used microbiological or composite reference standards for TB diagnosis. Inclusion was not restricted by setting or participant age. Study selection, quality appraisal using the QUADAS-2 tool, and data extraction were conducted independently by two reviewers. Thereafter, narrative synthesis of included studies, and comparison of signatures performance, was performed. Results We screened 1,580 records and included 12 studies evaluating 31 host-blood transcriptomic signatures in 10 test or validation cohorts of PLHIV that differentiated individuals with TB from those with HIV alone, latent Mycobacterium tuberculosis infection, or other diseases (OD). Two (2/10; 20%) cohorts were prospective (29 TB cases; 51 OD) and 8 (80%) case-control (353 TB cases; 606 controls) design. All cohorts (10/10) were recruited in Sub-Saharan Africa and 9/10 (90%) had a high risk of bias. Ten signatures (10/31; 32%) met minimum WHO Target Product Profile (TPP) criteria for TB triage tests. Only one study (1/12; 8%) evaluated prognostic performance of a transcriptomic signature for progression to TB in PLHIV, which did not meet the minimum WHO prognostic TPP. Conclusions Generalisability of reported findings is limited by few studies enrolling PLHIV, limited geographical diversity, and predominantly case-control design, which also introduces spectrum bias. New prospective cohort studies are needed that include PLHIV and are conducted in diverse settings. Further research exploring the effect of HIV clinical, virological, and immunological factors on diagnostic performance is necessary for development and implementation of TB transcriptomic signatures in PLHIV.

Background: Bloodstream infections caused by Enterobacterales show high frequency of antimicrobial resistance (AMR) in many Low- and Middle-Income Countries. We aimed to describe the variation in circumstances for management of such resistant infections in a group of African public-sector hospitals participating in a major research study. Methods: We gathered data from eight hospitals across sub-Saharan Africa to describe hospital services, infection prevention and antibiotic stewardship activities, using two WHO-generated tools. We collected monthly cross-sectional data on availability of antibiotics in the hospital pharmacies for bloodstream infections caused by Enterobacterales. We compared the availability of these antibiotics to actual patient-level use of antibiotics in confirmed Enterobacterales bloodstream infections (BSI). Results: Hospital circumstances for institutional management of resistant BSI varied markedly. This included self-evaluated infection prevention level (WHO-IPCAF score: median 428, range 155 to 687.5) and antibiotic stewardship activities (WHO stewardship toolkit questions: median 14.5, range 2 to 23). These results did not correlate with national income levels. Across all sites, ceftriaxone and ciprofloxacin were the most consistently available antibiotic agents, followed by amoxicillin, co-amoxiclav, gentamicin and co-trimoxazole. There was substantial variation in the availability of some antibiotics, especially carbapenems, amikacin and piperacillin-tazobactam with degree of access linked to national income level. Investigators described out-of-pocket payments for access to additional antibiotics at 7/8 sites. The in-pharmacy availability of antibiotics correlated well with actual use of antibiotics for treating BSI patients. Conclusions: There was wide variation between these African hospitals for a range of important circumstances relating to treatment and control of severe bacterial infections, though these did not all correspond to national income level. For most antibiotics, patient-level use reflected in-hospital drug availability, suggesting external antibiotics supply was infrequent. Antimicrobial resistant bacterial infections could plausibly show different clinical impacts across sub-Saharan Africa due to this contextual variation.

Background: The World Health Organization (WHO) recommends seasonal malaria chemoprevention (SMC) with sulfadoxine-pyrimethamine and amodiaquine for children aged 3 to 59 months, living in areas where malaria transmission is highly seasonal. However, due to widespread prevalence of resistance markers, SMC has not been implemented at scale in East and Southern Africa. An initial study in Uganda showed that SMC with SPAQ was feasible, acceptable, and protective against malaria in eligible children in Karamoja region. Nonetheless, exploration of alternative regimens is warranted since parasite resistance threats persist. Objective: The study aims to test the effectiveness of SMC with DP or SPAQ (DP-SMC & SPAQ-SMC), chemoprevention efficacy as well as the safety and tolerability of DP compared to that of SPAQ among 3-59 months old children in Karamoja region, an area of Uganda where malaria transmission is highly seasonal. Methods: A Type II hybrid effectiveness-implementation study design consisting of four components: 1) a cluster randomized controlled trial (cRCT) using passive surveillance to establish confirmed malaria cases in children using both SPAQ and DP; 2a) a prospective cohort study to determine the chemoprevention efficacy of SPAQ and DP (if SPAQ or DP clears sub-patent infection and provides 28 days of protection from new infection) and whether drug concentrations and/or resistance influence the ability to clear and prevent infection; 2b) a sub study examining pharmacokinetics of DP in children between 3 to Discussion: This study evaluates the effects of a clinical intervention on relevant outcomes whilst collecting information on implementation. Conclusion: This study will inform malaria policy in high-burden countries and contribute to progress in malaria control.

The coronavirus disease 2019 (COVID-19) pandemic has had severe implications worldwide, including increased adverse maternal and neonatal health outcomes. Vaccination is one way of protecting against these adverse health outcomes. However, in some low-resource settings, vaccine inequity has led to poor uptake of COVID-19 vaccination. There are very high rates of adolescent pregnancy in low-resource settings, which are likely to become even higher as we begin to see the full effects of COVID-19 lockdown measures, including school closures. Although the benefits of COVID-19 vaccination in adolescents are debated, we propose that adolescent girls should be prioritised in COVID vaccination roll out in low-resource settings. This is to provide protection from severe COVID-19 disease in pregnancy, preventing adverse maternal and neonatal health outcomes.

Background: Lateral flow assays (LFAs) for the rapid detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) provide an affordable, rapid and decentralised means for diagnosing coronavirus disease 2019 (COVID-19). Concentrating on urban areas in low- and middle-income countries, we examined whether ‘dynamic’ screening algorithms, that adjust the use of confirmatory polymerase chain reaction (PCR) testing based on epidemiological conditions, could reduce cost without substantially reducing the impact of testing. Methods: Concentrating on a hypothetical ‘second wave’ of COVID-19 in India, we modelled the potential impact of testing 0.5% of the population per day at random with LFA, regardless of symptom status. We considered dynamic testing strategies where LFA positive cases are only confirmed with PCR when LFA positivity rates are below a given threshold (relative to the peak positive rate at the height of the epidemic wave), compared to confirming either all positive LFA results or confirming no results. Benefit was estimated based on cumulative incidence of infection, and resource requirements, based on the cumulative number of PCR tests used and the cumulative number of unnecessary isolations. Results: A dynamic strategy of discontinuing PCR confirmation when LFA positivity exceeded 50% of the peak positivity rate in an unmitigated epidemic would achieve comparable impact to one employing PCR confirmation throughout (9.2% of cumulative cases averted vs 9.8%), while requiring 35% as many PCR tests. However, the dynamic testing strategy would increase the number of false-positive test results substantially, from 0.07% of the population to 1.1%. Conclusions: Dynamic diagnostic strategies that adjust to epidemic conditions could help maximise the impact of testing at a given cost. Generally, dynamic strategies reduce the number of confirmatory PCR tests needed, but increase the number of unnecessary isolations. Optimal strategies will depend on whether greater priority is placed on limiting confirmatory testing or false-positive diagnoses.

The Manhiça Health Research Centre (Manhiça HDSS) was established in 1996 in Manhiça, a rural district at Maputo Province in the southern part of Mozambique with approximately 49,000 inhabited households, a total population of 209.000 individuals, and an annual estimated birth cohort of about 5000 babies. Since 2016, Manhiça HDSS is implementing the Child Health and Mortality Prevention Surveillance (CHAMPS) program aiming to investigate causes of death (CoD) in stillbirths and children under the age of 5 years using, among other tools, the innovative post-mortem technique known as Minimally Invasive Tissue sampling (MITS). Both in-hospital and community pediatric deaths are investigated using MITS. For this, community-wide socio-demographic approaches (notification of community deaths by key informants, formative research involving several segments of the community, availability of free phone lines for notification of medical emergencies and deaths, etc.) are conducted alongside to foster community awareness, involvement and adherence as well as to compute mortality estimates and collect relevant information of health and mortality determinants. The main objective of this paper is to describe the Manhiça Health and Demographic Surveillance System (HDSS) site and the CHAMPS research environment in place including the local capacities among its reference hospital, laboratories, data center and other relevant areas involved in this ambitious surveillance and research project, whose ultimate aim is to improve child survival through public health actions derived from credible estimates and understanding of the major causes of childhood mortality in Mozambique.

Background Universal access to family planning services is a well-recognized human right and several countries and organizations are committed to this goal. Our objective was to identify countries who improved family planning coverage in the last 40 years and investigate which contexts enabled those advances. Methods Analyses were based on data from publicly available national health surveys carried out since 1986 in Egypt, Ethiopia, Rwanda, Afghanistan, Brazil, and Ecuador, selected based on previous evidence. We estimated demand for family planning satisfied with modern methods (mDFPS) for each country and explored inequalities in terms of wealth, women’s education, and women’s age. We also explored contextual differences in terms of women’s empowerment, percentage of population living in extreme poverty, and share of each type of contraceptive. To better understand political and sociocultural contexts, country case studies were included, based on literature review. Results Patterns of mDFPS increase were distinct in the selected countries. Current level of mDFPS coverage ranged between 94% in Brazil and 38% in Afghanistan. All countries experienced an important reduction in both gender inequality and extreme poverty. According to the share of each type of contraceptive, most countries presented higher use of short-acting reversible methods. Exceptions were Ecuador, where the most used method is sterilization, and Egypt, which presented higher use of long-acting reversible methods. In the first years analyzed, all countries presented huge gaps in coverage according to wealth, women’s education and women’s age. All countries managed to increase coverage over recent years, especially among women from the more disadvantaged groups. Conclusions Family planning coverage increased along with reductions in poverty and gender inequality, with substantial increases in coverage among the most disadvantaged in recent years. Policies involving primary health care services, provision of various methods, and high quality training of health providers are crucial to increase coverage.

Background: Tranexamic acid (TXA) reduces the risk of death and is recommended as a treatment for women with severe postpartum bleeding. There is hope that giving TXA shortly before or immediately after birth could prevent postpartum bleeding. Extending the use of TXA to prevent harmful postpartum bleeding could improve outcomes for millions of women; however, we must carefully consider the balance of benefits and potential harms. This article describes the protocol for a systematic review and individual patient data (IPD) meta-analysis to assess the effectiveness and safety of TXA for preventing postpartum bleeding, and to explore how the effects vary by underlying risk and other patient characteristics. Methods: We will search for prospectively registered, randomised controlled trials involving 500 patients or more assessing the effects of TXA in women giving birth. Two authors will extract data and assess risk of bias. IPD data will be sought from eligible trials. Primary outcomes will be life-threatening bleeding and thromboembolic events. We will use a one-stage model to analyse the data. Subgroup analyses will be conducted to explore whether the effectiveness and safety of TXA varies by underlying risk, type birth, maternal haemoglobin (Hb), and timing of TXA. Conclusions: This systematic review and IPD meta-analysis will address important clinical questions about the effectiveness and safety of the use of TXA for the prevention of postpartum bleeding that cannot be answered reliably using aggregate data and will inform the decision of who to treat. PROSPERO registration: CRD42022345775

The pantropic emergence of severe dengue disease can partly be attributed to the co-circulation of different dengue viruses (DENVs) in the same geographical location. Effective monitoring for circulation of each of the four DENVs is critical to inform disease mitigation strategies. In low resource settings, this can be effectively achieved by utilizing inexpensive, rapid, sensitive and specific assays to detect viruses in mosquito populations. In this study, we developed four rapid DENV tests with direct applicability for low-resource virus surveillance in mosquitoes. The test protocols utilize a novel sample preparation step, a single-temperature isothermal amplification, and a simple lateral flow detection. Analytical sensitivity testing demonstrated tests could detect down to 1,000 copies/µL of virus-specific DENV RNA, and analytical specificity testing indicated tests were highly specific for their respective virus, and did not detect closely related flaviviruses. All four DENV tests showed excellent diagnostic specificity and sensitivity when used for detection of both individually infected mosquitoes and infected mosquitoes in pools of uninfected mosquitoes. With individually infected mosquitoes, the rapid DENV-1, -2 and -3 tests showed 100% diagnostic sensitivity (95% CI = 69% to 100%, n=8 for DENV-1; n=10 for DENV 2,3) and the DENV-4 test showed 92% diagnostic sensitivity (CI: 62% to 100%, n=12) along with 100% diagnostic specificity (CI: 48–100%) for all four tests. Testing infected mosquito pools, the rapid DENV-2, -3 and -4 tests showed 100% diagnostic sensitivity (95% CI = 69% to 100%, n=10) and the DENV-1 test showed 90% diagnostic sensitivity (55.50% to 99.75%, n=10) together with 100% diagnostic specificity (CI: 48–100%). Our tests reduce the operational time required to perform mosquito infection status surveillance testing from > two hours to only 35 minutes, and have potential to improve accessibility of mosquito screening, improving monitoring and control strategies in low-income countries most affected by dengue outbreaks.

Background: Since the recommendation of voluntary medical male circumcision (VMMC) to reduce the risk of heterosexually acquired HIV, a number of adolescent boys and men in 15 priority countries in Africa have been circumcised. Our primary goal was to identify the incidence of adverse events (AEs) associated with VMMC and to assess the safety profile among adolescent boys 10 – 14 years. Methods: We searched the databases MEDLINE and Embase, WHO, and conference abstracts from 2005 to 2019. The incidence of AEs was estimated by type of AE, size of study and age. Results: We retained 40 studies. Severe and moderate AEs overall were estimated at 0.30 per 100 VMMC clients with wide variability per study type. A higher rate was noted in small and moderate scale programmes and device method research studies compared with larger scale programmes. There was a limited number of studies reporting AEs among younger adolescent boys and they had higher infection-related AEs than those aged 20 years and older. Case studies noted rare AEs such as necrotizing fasciitis, tetanus, and glans injury. Conclusions: AE rates were comparable to those from the randomized controlled trials (RCTs) that led to recommendations and implementation of VMMC in high HIV burden countries, despite being implemented in low resource settings. Clients over time have increasingly included adolescents under the age of 15 years. Studies suggest potentially higher risks in this age group. As VMMC services are sustained, patient safety surveillance systems and promoting a patient safety culture are crucial to identify and mitigate potential harms from medical male circumcision.

The chapter equips the reader with a basic understanding of robust psychometric methods that are needed to turn developmental milestones into measurements, introducing the fundamental issues in defining a unit for child development and demonstrates the relevant quantitative methodology. It reviews quantitative approaches to measuring child development;introduces the Rasch model in a non-technical way;shows how to estimate model parameters from real data;puts forth a set of principles for model evaluation and assessment of scale quality;analyses the relation between early D-scores and later intelligence;and compares the D-scores from three studies that all use the same instrument.

Background: Each year, nearly 300,000 women and 5 million fetuses or neonates die during childbirth or shortly thereafter, a burden concentrated disproportionately in low- and middle-income countries. Identifying women and their fetuses at risk for intrapartum-related morbidity and death could facilitate early intervention. Methods: The Limiting Adverse Birth Outcomes in Resource-Limited Settings (LABOR) Study is a multi-country, prospective, observational cohort designed to exhaustively document the course and outcomes of labor, delivery, and the immediate postpartum period in settings where adverse outcomes are frequent. The study is conducted at four hospitals across three countries in Ghana, India, and Zambia. We will enroll approximately 12,000 women at presentation to the hospital for delivery and follow them and their fetuses/newborns throughout their labor and delivery course, postpartum hospitalization, and up to 42 days thereafter. The co-primary outcomes are composites of maternal (death, hemorrhage, hypertensive disorders, infection) and fetal/neonatal adverse events (death, encephalopathy, sepsis) that may be attributed to the intrapartum period. The study collects extensive physiologic data through the use of physiologic sensors and employs medical scribes to document examination findings, diagnoses, medications, and other interventions in real time. Discussion: The goal of this research is to produce a large, sharable dataset that can be used to build statistical algorithms to prospectively stratify parturients according to their risk of adverse outcomes. We anticipate this research will inform the development of new tools to reduce peripartum morbidity and mortality in low-resource settings.

A Maternal and Child Health Surveillance System (MCHSS) was set up by the department of pediatrics and child health, Aga Khan University, Pakistan in peri-urban areas of Karachi to provide a platform for various research projects. It was established in five low-socioeconomic communities in a stepwise manner between 2003 and 2014. The total area currently under surveillance is 18.6 km2 covering a population of 302,944. We maintain a record of all births, deaths, pregnancies, and migration events by two monthly household visits. Verbal autopsies for stillbirths, deaths of children under the age of five years and adult female deaths are also conducted. For over a decade, the MCHSS has been a platform for a variety of studies describing the burden of various infectious diseases like typhoid, pneumonia and diarrhea, evaluation of effectiveness of various treatment regimens for neonatal sepsis, assessment of the acceptance of hospitalized care, determination of the etiology of moderate to severe diarrhea, assessment of burden and etiology of neonatal sepsis and a multi-center cohort study measuring the burden of stillbirths, neonatal and maternal deaths. More recently we have also established a bio-repository of the well-characterized maternal and newborn cohort. Through a well-established MCHSS, we aim to provide concrete evidence base to guide policy makers to make informed decisions at local, national, and international levels.

Background: Anemia causes debilitating outcomes for women and children, and can be of multifactorial etiology, soil transmitted helminth (STH) infection being one of them. The Bangladeshi government does not have any regular deworming program for women of reproductive age (WRAs), who constitute an important portion of the population. Hence, we conducted this study to generate evidence on the effect of regular deworming on STH infection status and anemia status of WRAs in rural Bangladesh. Methods: This was a quasi-experimental study conducted in rural Bangladesh using existing healthcare delivery platform (Community Clinics) for mass deworming of WRAs. Catchment areas of two community clinics constituted the intervention arm, where the WRAs received two cycles of deworming four months apart on top of government recommended iron-folate supplementation (IFA), and catchment areas of two different community clinics were considered as the control arm where the study population received IFA but no deworming medication. Baseline and endline surveys were conducted on randomly selected participants to measure prevalence of anemia and STH infection using HemoCue 201+ and Kato-Katz respectively. Results: The study area contained 4791 women aged 15-49 years. Among them, 2441 lived in the intervention area and 2350 lived in the control area. Compliance to deworming medication and IFA was 82% (2001 out of 2441) and 79% (1938 out of 2441) for the two cycles, respectively. In the baseline survey there was no significant difference in prevalence of anemia between the intervention and control arms (63.7% vs 65.7%; p=0.522). However, the endline survey yielded significant difference in anemia prevalence between the arms (47.5% vs 65.7%, p Conclusions: Our study clearly showed that regular deworming of WRA benefits their anemia and STH infection status.

Background: In designing responses to the COVID-19 pandemic, it is critical to understand what has already worked well. We aimed to identify countries with emerging success stories from whom policymakers might draw important lessons. Methods: We developed a process to first include countries with large enough populations that results were unlikely to be due to chance, that had sufficient cases for response mechanisms to be tested, and that shared the necessary publicly available data. Within these countries, we looked at indicators suggesting success in terms of detecting disease, containing the outbreak, and treating those who were unwell. To support comparability, we measured indicators per capita (per million) and across time. We then used the indicators to identify three countries with emerging success stories to include some diversity in global region, population demographics and form of government. Results: We identified 66 countries that met our inclusion criteria on 18th May 2020. Several of these countries had indicators of success against the set indicators at different times in the outbreak. Vietnam had high levels of testing and successful containment with no deaths reported. South Korea had high levels of testing early in the outbreak, supporting containment. Germany had high levels of sustained testing and slower increases in cases and deaths than seen in other comparable settings. Conclusions: At the time of our assessment, Vietnam and South Korea were able to contain the outbreak of COVID-19 and avoid the exponential growth in cases seen elsewhere. Germany had more cases and deaths, but was nevertheless able to contain and mitigate the outbreak. Despite the many limitations to the data currently available, looking at comparative data can help identify countries from whom we can draw lessons, so that countries can inform and adapt their strategies for success in response to COVID-19.

Background: Adolescence is a time of psycho-social and physiological changes, with increased associated health risks including vulnerability to pregnancy, HIV, sexually transmitted infections, and gender-based violence. Adolescent learners, from three townships in South Africa, participated in a 44 session, after-school asset-building intervention (GAP Year), over 2 years providing sexual and reproductive health (SRH) education. This paper explores adolescent learners’ SRH, sexual risk and rights knowledge; perceptions about transactional sex; and contraceptive method preferences and decision-making practices. Methods: The intervention was conducted in 13 secondary schools across Khayelitsha, Thembisa, and Soweto, South Africa. A baseline survey collected socio-demographic data prior to the intervention. Overall, 26 focus group discussions (FGDs): 13 male and 13 female learner groups, purposively selected from schools, after completing the intervention (2 years after baseline data collection). Descriptive analyses were conducted on baseline data. Qualitative data were thematically coded, and NVivo was used for data analysis. Results: In total, 194 learners participated in the FGDs. Mean age at baseline was 13.7 years (standard deviation 0.91). Participants acquired SRH and rights knowledge during the GAP Year intervention. Although transactional sex was viewed as risky, some relationships were deemed beneficial and necessary for material gain. Negative healthcare provider attitudes were the main barrier to healthcare service utilisation. There was awareness about the benefits of contraceptives, but some myths about method use. The injectable was the preferred contraceptive method, followed by the implant, with equal preference for condoms and oral pill. Conclusions: An afterschool intervention at school is a viable model for the provision of SRH and rights education to learners. Recommendations include the need for risk reduction strategies in the curriculum, dealing with misconceptions, and the promotion of informed decision making. Endeavours to ensure health services are youth friendly is a priority to limit barriers to accessing these services.

Background: Pneumonia and diarrhoea are the leading causes of childhood mortality and morbidity worldwide. The gut-lung axis is associated with disease, and these common infections, especially the parasite Cryptosporidium, are associated with malnutrition. We sought to evaluate the association of respiratory and gastrointestinal (GI) pathogens with short-term growth among children hospitalised with diarrhoeal disease. Methods: In this sub-study, we followed 27 children (two-24 months) who tested positive for Cryptosporidium spp. for eight weeks with two weekly sampling of the respiratory and GI tract. Respiratory and stool pathogens were detected using quantitative molecular methods. Nutritional outcomes were assessed as length-for-age (LAZ), weight-for-length (WLZ) and weight-for-age (WAZ) z-scores. Changes over the study period were compared using repeated analysis of variance and mixed effects model analysis. Results: In this period,104 sputum and stool samples were collected. All stool samples had at least one pathogen detected, with an average of 5.1 (SD 2.1) stool pathogens, compared to 84% of the sputum samples with an average 3.5 (SD 1.8). Diarrhoeagenic E. coli were the most common stool pathogens (89%), followed by Cryptosporidium (57.6%) and Adenovirus pan (41%). In sputum, Streptococcus pneumoniae was the most prevalent pathogen (84%), followed by hinovirus (56%) and Moraxella catarrhalis (50%). There was a significant change in WAZ over the follow-up period. Children who had ≥3 GI pathogens had significantly a lower LAZ mean score at enrolment (-1.8 [SD 1.4]) and across the follow-up period. No relationship between respiratory pathogens and short-term growth was observed. Out of 49 sputum samples that had ≥3 pathogens, 42 (85%) concurrent stool samples had ≥3 GI pathogens. Conclusions: Among young children hospitalised with diarrhoea, multiple GI and respiratory pathogens were prevalent over an eight-week follow-up period. The presence of more GI, but not respiratory, pathogens was significantly associated with reduced short-term growth.

Background: Previous studies of infants born to HIV-positive mothers have linked HIV exposure to poor outcomes from gastrointestinal and respiratory illnesses, and to overall increased mortality rates. The mechanism behind this is unknown, but it is possible that differences in the nasopharyngeal (NP) microbiome between HIV-unexposed and HIV-exposed infants could play a role in perpetuating some outcomes. Methods: We conducted a longitudinal analysis of 170 NP swabs of healthy HIV-exposed, uninfected (HEU; n=10) infants and their HIV(+) mothers and HIV-unexposed, uninfected (HUU; n=10) infants and their HIV(-) mothers. These swabs were identified from a sample library collected in Lusaka, Zambia between 2015 and 2016. Using 16S rRNA gene sequencing, we characterized the maturation of the microbiome over the first 14 weeks of life to determine what quantifiable differences exist between HEU and HUU infants, and what patterns are reflected in the mothers' NP microbiomes. Results: In both HEU and HUU infants, Staphylococcus and Corynebacterium began as primary colonizers of the NP microbiome but were in time replaced by Dolosigranulum, Streptococcus, Moraxella and Haemophilus. When studying differences between infants, the microbe Staphylococcus haemolyticus indicated a distinctive high association with HIV exposure at birth, even when accounting for the interaction between HIV exposure status and time of sampling. When comparing infants to their mothers with paired analyses, HEU infants’ NP microbiome composition was only slightly different from their HIV(+) mothers at birth or 14 weeks, including in their carriage of S. pneumoniae, H. influenzae, and S. haemolyticus. Conclusions: Our analyses indicate that the HEU infants in our study exhibit subtle differences in the NP microbial composition throughout the sampling interval. Given our results and the sampling limitations of our study, we believe that further research must be conducted in order to confidently understand the relationship between HIV exposure and infants’ NP microbiomes.

Background: The study objective was to explore opinions, identify experiences, and describe perspectives on the acceptability of intravenous (IV) iron to treat anaemia in pregnancy and identify potential barriers and facilitators of introducing IV iron in the Malawian healthcare system. Methods: We conducted 15 in-depth interviews and two focus group discussions with pregnant women, and seven in-depth interviews with health workers at a community-based health centre in Blantyre and a tertiary hospital in Zomba. Results: Most women who used IV iron treatment during the second trimester of pregnancy reported feeling better and stronger after receiving the intervention. Women perceived that IV iron treatment worked faster and increased their haemoglobin count. However, cultural beliefs that IV iron treatment will cause miscarriage and the perception that study procedures involved Satanism and vampirism practices were barriers to acceptability. Health workers found IV iron treatment easy to administer because it is a single-dose treatment, simultaneously reducing the burden for pregnant women taking daily oral iron tablets. However, health workers expressed concerns about the costs and the need to train health workers before the large-scale implementation and integration of IV iron treatment into Malawi’s routine care. Conclusions: Despite the perceived concerns and challenges experienced in participating in the first IV iron infusion trial in Malawi, participants’ reflections suggest that IV iron infusion is acceptable for treating iron-deficiency anaemia in pregnancy. Participant advocate groups can offer a peer-to-peer education approach to sensitize and engage community members on the benefits of treatment and dispel concerns when the country contemplates integrating IV iron infusion for treating anaemia in pregnancy in Malawi.

Background Universal access to family planning services is a well-recognized human right and several countries and organizations are committed to this goal. Our objective was to identify countries who improved family planning coverage in the last 40 years and investigate which contexts enabled those advances. Methods Analyses were based on data from publicly available national health surveys carried out since 1986 in Egypt, Ethiopia, Rwanda, Afghanistan, Brazil, and Ecuador, selected based on previous evidence. We estimated demand for family planning satisfied with modern methods (mDFPS) for each country and explored inequalities in terms of wealth, women’s education, and women’s age. We also explored contextual differences in terms of women’s empowerment, percentage of population living in extreme poverty, and share of each type of contraceptive. To better understand political and sociocultural contexts, country case studies were included, based on literature review. Results Patterns of mDFPS increase were distinct in the selected countries. Current level of mDFPS coverage ranged between 94% in Brazil and 38% in Afghanistan. All countries experienced important reduction in both gender inequality and extreme poverty. According to the share of each type of contraceptive, most countries presented higher use of short-acting reversible methods. Exceptions were Ecuador, where the most used method is sterilization, and Egypt, which presented higher use of long-acting reversible methods. In the first years analyzed, all countries presented huge gaps in coverage according to wealth, women’s education and women’s age. All countries managed to increase coverage over recent years, especially among women from the more vulnerable groups. Conclusions Family planning coverage increased along with reductions in poverty and gender inequality, with substantial increases in coverage among the most vulnerable in recent years. Policies involving primary health care services, provision of various methods, and high quality training of health providers are crucial to increase coverage.

Background: This study sought to understand private sector reporting on family planning in Kenya’s health information system (KHIS). We approached this through three lenses: governance, procedural and technical. Our study looked at these areas of interest in Kenya, complemented by deeper exploration in Nairobi County. Methods: The study used mixed methods drawing on analysis from the KHIS and surveys, complemented by desk review. The qualitative research entailed group discussions with public sector personnel while more in-depth qualitative interviews were done with public and private sector respondents. A framework matrix was developed for the qualitative analysis. The study was approved by the Ministry of Health in March 2022 and conducted over the period March - May 2022. Results: From a governance lens, private sector respondents recognised the importance of registry and reporting as a government policy requirement. From a procedural lens, private sector respondents saw reporting procedures as duplicative and parallel processes as reports are not generated through digitised information systems. From a technical lens, private sector reporting rates have improved over time however other data quality issues remain, which include over- and under-reporting of family planning services into KHIS. Secondary analysis for Nairobi County shows that the private facility contribution to family planning has declined over time while family planning access through pharmacies have grown over the same period; there is no visibility on this shift within the KHIS. Changes in private sector family service provision have implications for assumptions underpinning modern contraceptive modelled estimates and programmatic decision-making. Conclusions: There is limited monitoring of the incentives and disincentives for reporting by private health facilities into the KHIS. These have changed over time and place. Sustained private sector engagement is important to align incentives for reporting as is greater visibility on the role of pharmacies in family planning.

Background: Digital process monitoring and evaluation tools designed to capture near-to-real-time intervention data paired with feedback loops have the potential to innovate intervention delivery. Objective: To describe how a multilevel social norms field trial (RANI) is using feedback loops to enhance intervention delivery. Methods: We use a mixed-methods process evaluation design to monitor the Reduction of Anemia through Normative Innovations (RANI) project; a three-year randomized control trial which aims to lower rates of anemia among women in Odisha, India. Surveys and structured observation monitor fidelity to implementation and acceptability of implementation activities among study participants. Quantitative data evaluates implementation dose, coverage, exposure, and reach of intervention activities, and qualitative data will delve more deeply into reasons for high or low functioning. Iron folic acid supplement supply and demand are also monitored for stock-outs. Data collected from 130 intervention villages is processed, visualized, and triangulated in near to real-time via Real-time Monitoring for Knowledge Generation (RPM4K), a locally developed software application. Data visualization products facilitate the examination of monitoring data to mitigate bottlenecks and identify and implement tweaks to our intervention delivery strategy on an ongoing basis. Discussion: Feedback loops facilitate timely course corrections. Feedback loops can also engender a shared understanding of ground realities for a geographically dispersed and culturally diverse team. Leveraging feedback loops, we identify opportunities to provide on-going supportive supervision for our community facilitators promoting joint problem-solving, and communication. Monthly media and hemoglobin level demonstration strategies are informed by participant engagement and acceptability. Stock-outs of iron folic acid tablets activate contingency plans to mobilize local stakeholders and advocate for timely resolutions. Unintended effects are monitored based on ongoing feedback from community facilitators. Conclusions: Documenting our processes can inform the future implementation or scale up of similar projects embracing feedback loops to iterate and innovate their intervention delivery.

Background: Although global mortality rates in children under 5 years have decreased substantially in the last 30 years, there remain around 2.6 million stillbirths and 2.9 million neonatal deaths each year. The majority of these deaths occur in Africa and South Asia. To reduce perinatal deaths in East Africa, knowledge of the burden, but also the risk factors and causes of perinatal deaths are crucial. To the best of our knowledge, reviews have previously focused on the burden of perinatal deaths; here we aim to synthesize evidence on the burden, causes, and risk factors for perinatal mortality in East Africa. Methods: We will conduct a systematic literature search in Medline, Web of Science, EMBASE, Global Health, SCOPUS, Cochrane Library, CINAHL, HINARI, African Index Medicus, African Journals Online (AJOL), and WHO African Regional Office (AFRO) Library. We will include studies from 2010 to 2022, and to facilitate the inclusion of up-to-date data, we will request recent data from ongoing surveillance in the region, such as the Child Health and Mortality Prevention Surveillance (CHAMPS) network and Health and Demographic Surveillance sites (HDSS sites). To assess the quality of included studies we will use the Joanna Briggs Institute quality assessment tool for observational and trial studies. We will analyze the data using STATA version 17 statistical software and assess heterogeneity and publication bias by Higgins’ I2 and funnel plot, respectively. Conclusions: This systematic review protocol will search for published studies, and seek unpublished data, on the burden, causes, and risk factors of perinatal mortality in East Africa. Findings will be reported and gaps in the evidence base identified, with recommendations, with the ultimate aim of reducing perinatal deaths.